Drug Trials

A PanACEA Capacity Development Project

MMRC: Site Principal Investigator: Andrea Rachow, MD, Co-Site PI: Issa Sabi

Munich: Protocol Chair: Norbert Heinrich

Purpose
Early Bactericidal Activity (EBA) Studies are currently the eye of the needle in the anti-TB drug development process, with limited site capacity slowing down phase 2 testing of new anti-TB drug candidates. To address this problem, PanACEA (Pan-African Consortium for Evaluation of Antituberculosis Antibiotics) has decided to develop a Tanzanian EBA facility consisting of MMRC and Kilimanjaro Clinical Research Institute (KCRI).

OEBA is designed as a platform to establish capacity for Early Bactericidal Activity Studies in these sites, and will provide the opportunity to research additional questions around TB treatment and monitoring of treatment success.

Within the newly founded PanACEA Consortium, three European universities (LMU, University College of London, University St.Radboud, Nijmegen, the Netherlands)  are collaborating with 10 African study sites to accelerate clinical development of new anti-tuberculosis drugs, meeting international quality standards. 

The working group has played a role in initiating this consortium, and is responsible for clinical development (phase II) of the drug candidate SQ109.

SQ109 was developed by Sequella, Inc., and exhibited good activity against tuberculosis in animal models, as well as good tolerability when given to healthy volunteers. Further testing of the drug candidate for its efficacy in human tuberculosis will be performed within a public-private-partnership in Africa. Study design and study coordination will be done by Dr Hoelscher and his working group.

International multicenter trials are planned to be carried out in South Africa, Zambia, Tanzania, and Gabon. International standards for quality and ethical study conduct (Good Clinical Practice, Declaration of Helsinki) will be met, to ensure protection of human study subjects.

Chief Investigator: Dr. M. Hoelscher, MD, PhD, Associate Professor
Project Coordinator: S. Henne, MSc
Medical Expert: Dr. N. Heinrich, MD

This is a randomised placebo – controlled double blind trial comparing two treatment shortening regimens with the standard regimen (two months ethambutol, isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and rifampicin) namely 1) two months moxifloxacin, isoniazid, rifampicin and pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin and 2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide followed by two months moxifloxacin and rifampicin for the treatment of adults with pulmonary tuberculosis.

Purpose
The commonly used drugs to treat tuberculosis are rifampicin, isoniazid, ethambutol and pyrazinamide. Standard therapy consists of a combination of all four drugs for 2 months followed by a 4 months period of rifampicin and isoniazid combined. Previous studies in animals and in humans suggest that a new drug called moxifloxacin may also be an effective treatment in tuberculosis.  Moreover, promising laboratory studies on mice suggest that moxifloxacin may enable the total duration of chemotherapy to be reduced to four months, which would be a significant improvement for patients taking medication for tuberculosis.

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